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NCT Number: NCT01547611

Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial

Many patients with cervical disc disease have long-lasting and complex symptoms with chronic pain, low levels of physical and psychological function and sick-leave. Surgery on a few segmental levels might be expected to solve the disc-specific pain but not the non-specific neck pain and the patients'illness. As much as 2/3 of the patients have been reported to have remaining physical/ psychological disability long-term after surgery. A structured physiotherapy programme after surgery may improve patients'function and return to work. The main purpose of the study is to evaluate what a well structured rehabilitation program adds to the customary treatment after surgery for radiculopathy due to cervical disc disease in respect to function, disability, workability and cost effectiveness. The study is a prospective randomised controlled multi-centre study, with an independent and blinded investigator comparing two alternatives of rehabilitation. 200 patients in working age, with cervical disc disease with clinical findings and symptoms of cervical nerve root compression will be included after informed consent. After inclusion in the study patients will be randomised to one out of the two alternatives of physiotherapy, (A) customary treatment (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised and structured program of neck specific exercises combined with a behavioural approach plus customary treatment. Patients will be evaluated both clinically and with questionnaires before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main outcome variable are neck specific disability. Cost-effectiveness will be calculated. The inclusion will preliminary be closed 2012. The study could contribute to a better clinical decision making, a better health care which will reduce physical, mental and social costs for the patients, and improve the rates of patients returning to and staying at work.

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Key information

Conditions

Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical and Health Sciences, Linköping, Östergötland County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be included from four Neurosurgical clinics in the south of Sweden and the rehabilitation will be performed in primary care units in several counties.
  • Patients in working age, with MRI-verified cervical disc disease with clinical findings and symptoms of cervical nerve root compression and who have had surgery with anterior decompression and fusion or posterior surgery (foraminotomy/ laminectomy) will be included after informed consent.

Exclusion criteria

  • Patients with myelopathy or with a disease or trauma contraindicated to perform the treatment program or the measurements will be excluded and so also patients with lack of familiarity of the Swedish language or with known drug abuse.

Treatment and study plan

Customary treatment

Other

The staff at the Neurosurgical clinic will give the patient ordinary pre- and postoperative information. The physiotherapist at the Neurosurgical clinic informs the patients what to avoid the first weeks after surgery and the importance of a good posture and ergonomic thinking in daily life. The patient is also instructed how to do exercises for the shoulder range of motion. Patients have ordinary post-surgery visit to the surgeon and to the physiotherapist about 6 weeks after the surgery, where physiotherapist instructs the patient in exercises for active neck range of motion.

Structured behavioural medicine program

Other

The behavioural medicine program includes functional behavioural analysis of the problem, medical exercise therapy, strategies to increase self-efficacy in activities and problem-solving strategies for coping with disability.

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: Baseline and change after 3, 6, 12 and 24 months follow-up. The outcome measures is going to report a change over time.

    NDI will be measured at baseline before surgical intervention. Change from baseline in NDI will be measured at 3, 6, 12 and 24 months follow-up.

    NDI will be used to investigate Neck specific disability. The 10 sections in the questionnaire are rated on a six-point scale (0-5 point). The scores for all sections are added together and transformed to percentages (where 0% is no pain or difficulties and 100% is highest score for pain and difficulty on all items.

Secondary outcomes

  1. Pain intensity on visual analogue scale (VAS 0-100mm)

    Time frame: The outcome measure is going to report a change over time from baseline and at 6 weeks, 3, 6, 12 and 24 months follow-up

    Pain intensity of neck pain, arm pain and headache, respectively

  2. Dizziness/ unsteadiness measured on a visual analogue scale (VAS) 0-100mm

    Time frame: The outcome measure is going to report a change over time from baseline to 3, 6, 12 and 24 months follow-up

    Dizziness/ unsteadiness measured on a VAS-scale (0=no problems, 100= pretty severe problems).

  3. Modified Odom scale and a question if how important the change is.

    Time frame: The outcome measure is going to report a change over time from before surgery to 6 weeks, 3, 6, 12 and 24 months follow-up.

    A 1 to 6 point scale of treatment outcome. 1=recovered, 2=much better, 3=better, 4=unchanged, 5=worse, 6= much worse. How important is the change on a 0 to 10 point horizontal scale (0=not at all important, 10= very important).

  4. Expectations of treatment fulfilled

    Time frame: The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up.

    Fulfillment of the expectations for surgery at follow-ups was measured on a four-grade scale (1=yes, completely; 2=yes, partially; 3=no, not at all; or 4= do not know).

  5. Background data

    Time frame: Mainly before treatment started. Some basic background data are also asked at the follow-ups at 6 weeks, 3, 6, 12 and 24 months to control for variations over time.

    Pain history, pain debute, pain duration, pain medication, other diseases and problems than from the neck, age, sex, smoking, family and social life, expectations of the treatment, care seeking, type of work

  6. Vocational situation

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Questionns about sick-leave, ergonomics, expectations of being able to work in 6 months, work ability index

  7. Pain-drawing

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Character of pain, number of pain localisation and distributions of symptoms

  8. Zung questionnaire

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  9. MSPQ questionnaire

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  10. Distress and risk assessment method (DRAM)

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Zung and MSPQ questionnaires will be combined in the DRAM instrument

  11. Patient Enablement Instrument (PEI)

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  12. Coping Strategies Questionnaire

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  13. Work Ability Index

    Time frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  14. Physical activity/ exercise habits

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  15. Symptom satisfaction

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    How patients would feel about having their current neck symptoms for the rest of their lives was rated on a seven grade scale (1= delighted, 7=terrible).

  16. Pain frequency and pain medication

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  17. Self-efficacy scale

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    "People´s beliefs about their capabilities to produce designated levels of performance that exercise influence overe events that affect their lives" Self efficacy (Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident).

  18. Question about re-surgery

    Time frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Descriptive data

  19. EuroQuol five dimensions self report (EQ-5D) and EuroQuol thermometer

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Health realted quality of life

  20. Multidimensional Pain Inventory, Swedish version (MPI-S), MPI-S significant others and open questions

    Time frame: Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Relationship and support from spouses

  21. Neurological status

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Questions of numbness and tinglings in the arm and hand and pain distribution. Clinical examination: sensibility, reflexes, motor function.

  22. Patient Specific Functional Scale (PSFS)

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

  23. Physical clinical outcome measures

    Time frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.

    Range of motion in the neck, head repositioning accuracy (cervical kinesteshia), hand strength, balance (sharpened Romberg, walking in a figure of eight), neck muscle endurance

  24. Patients income

    Time frame: At baseline and at 1 and 2 years follow up. The outcome is going to report a change over time

    Will be used for health echonomic calculations

  25. Copy of the sick-leave receipt from the surgeon

    Time frame: After surgery (baseline, before physiotherapy started)

    Copy of the sickness certificate written by the physician. The certificate will be analysed due to quality with the emphasis on how the cervical radiculopathy impact on function and work ability and due to the quality of sickness certificate in relation to Swedish insurance office rules.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Karolinska University Hospital
  • Lund University Hospital
  • Ryhov County Hospital
  • University Hospital, Linkoeping

Registry information

Official study title

Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2012
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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